Dosing & Uses
Dosage Forms & Strength
ophthalmic emulsion
- 0.05% (Restasis, generic; single-use)
- 0.05% (Restasis Multidose)
- 0.1% (Verkazia; single-dose vial)
ophthalmic solution
- 0.09% (Cequa; single-use vial)
Keratoconjunctivitis Sicca
Cequa, Restasis
Indicated to increase tear production associated with keratoconjunctivitis sicca (dry eye)
Instill 1 drop BID in each eye ~12 hr apart
If using single-dose vial, discard immediately after using in both eyes
Vernal Keratoconjunctivitis
Verkazia only
Indicated for vernal keratoconjunctivitis (VKC) in children and adults
Instill 1 drop QID (morning, noon, afternoon, and evening) into affected eye(s)
May discontinue treatment once signs and symptoms have resolved
If recurs, treatment may be reinitiated
Corneal Melting (Orphan)
Orphan designation for use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer
Orphan sponsor
- Orphan indication sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534
Prevention of Graft Rejection
Orphan designation for treatment of patients at high risk of graft rejection following penetrating keratoplasty
Orphan sponsor
- Orphan sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534
Keratoconjunctivitis
Orphan designation for treatment of herpes simplex virus stromal keratitis
Orphan sponsor
- NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France
Keratoconjunctivitis Sicca
Orphan designation for treatment of severe keratoconjunctivitis sicca associated with Sjögren's syndrome
Orphan sponsor
- University Of Georgia; College of Veterinary Medicine, Department of Small Animal Medicine; Athens, GA 30602
Corneal Graft Rejection
Orphan designation for prevention of corneal graft rejection
Orphan sponsor
- NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France
Dosing Considerations
Restasis
- Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctual plugs
- Not studied in patients with history of herpes keratitis
Dosage Forms & Strength
ophthalmic emulsion
- 0.05% (Restasis, generic; single-use)
- 0.05% (Restasis Multidose)
- 0.1% (Verkazia; single-dose vial)
Keratoconjunctivitis Sicca
Restasis only
<16 years: Not studied
≥16 years
- Indicated to increase tear production associated with keratoconjunctivitis sicca (dry eye)
- Instill 1 drop BID in each eye ~12 hr apart
- If using single-dose vial, discard immediately after using in both eyes
Vernal Keratoconjunctivitis
Verkazia only
≥4 years
- Indicated for vernal keratoconjunctivitis (VKC) in children and adults
- Instill 1 drop QID (morning, noon, afternoon, and evening) into each affected eye
- May discontinue treatment once signs and symptoms have resolved
- If recurs, treatment may be reinitiated
Dosing Considerations
Restasis
- Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctual plugs
- Not studied in patients with a history of herpes keratitis
Adverse Effects
>10%
Verkazia
- Eye pain (12%)
1-10%
Restasis
-
1-5%
- Conjunctival hyperemia
- Discharge
- Epiphora
- Eye pain
- Foreign body sensation
- Stinging
- Visual disturbance (eg, blurring)
Verkazia
- Eye pruritus (8%)
- Ocular discomfort (6%)
- Visual acuity reduced (5%)
- Cough (5%)
- Ocular hyperemia (4%)
- Headache (4%)
- Upper respiratory tract infection (2%)
Postmarketing Reports
Hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea)
Superficial injury of the eye (from the vial tip touching the eye during administration)
Warnings
Contraindications
Known or suspected hypersensitivity to any of the ingredients in the formulation
Cautions
Remove contact lenses prior to administration
Do not touch eyelids with vial tip to avoid contamination
Do not use with contact lenses; lenses may be reinserted 15 minutes following administration ophthalmic emulsion/solution
Patients with decreased tear production typically should not wear contact lenses
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies of administration in pregnant females to inform a drug-associated risk
Infertility
- No data are available on drug effects on human fertility
- No impairment of fertility reported in animals receiving intravenous cyclosporine
Animal data
- Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses
- Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations; doses (normalized to body weight) were ~320 times higher than the daily maximum recommended human ophthalmic dose of 0.015 mg/kg/day
Lactation
There is no information regarding drug presence in human milk following topical administration or on effects on breastfed infants and milk production
Administration of oral cyclosporine to rats during lactation did not produce adverse effects in offspring at clinically relevant doses
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Cequa and Restasis
- Exact mechanism of action is not known
- Calcineurin inhibitor; immunosuppressive agent when administered systemically
- In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eyes, cyclosporine emulsion is thought to act as a partial immunomodulator
Verkazia
- Exact mechanism of action for VKC is unknown
- Following ocular administration, cyclosporine is believed to act by blocking the release of pro-inflammatory cytokines (eg, IL-2)
Absorption
Verkazia
- Peak plasma concentration: 0.67 ng/mL
Cequa
- Blood concentrations (for multiple doses): Either not detectable or marginally above the lower limit of assay quantitation of 0.100 ng/mL (range 0.101- 0.195 ng/mL) for up to 2 hours after a single dose, and up to 4 hours after multiple dose
Restasis
- Drug accumulation: Not detectable after 12 months of treatment
Administration
Ophthalmic Administration
Ophthalmic use only
Single-use solution or emulsion: After opening for administration to one or both eyes use immediately, and discard remaining contents immediately
Do not administer while wearing contact lenses; remove contacts prior to administration; contacts may reinsert 15 minutes following administration
Restasis
- Invert vial a few times to obtain uniform, white, opaque emulsion before use
- May be used concomitantly with artificial tears, allowing a 15-minute interval between products
Verkazia
- Gently shake the single-dose vial several times to obtain a uniform, white, opaque
- emulsion before use
- Missed dose: Continue treatment as normal, at the next scheduled administration
-
Multiple topical ophthalmic products being use
- Eye drops: Administer eye drops at least 10 minutes apart to avoid diluting products
- Eye ointment, gel, or other viscous eye drops: Administer Verkazia 10 minutes before administration
Storage
After opening the aluminum pouch, keep the single-dose vial in the pouch to protect from light and avoid evaporation
Discard any opened individual single-dose vial with any remaining emulsion immediately after use
Do NOT freeze
Emulsion: Store at 15-25°C (59-77°F)
Solution: Store at 20-25°C (68-77°F); store single-use vials in the original foil pouch
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Restasis MultiDose ophthalmic (eye) - | 0.05 % drops |  | |
| Sandimmune oral - | 100 mg capsule |  | |
| Sandimmune oral - | 100 mg/mL solution |  | |
| Sandimmune oral - | 25 mg capsule |  | |
| cyclosporine oral - | 100 mg capsule |  | |
| cyclosporine oral - | 25 mg capsule |  | |
| cyclosporine intravenous - | 250 mg/5 mL solution |  | |
| cyclosporine intravenous - | 250 mg/5 mL solution |  | |
| cyclosporine intravenous - | 250 mg/5 mL solution |  | |
| Sandimmune intravenous - | 250 mg/5 mL solution |  | |
| Restasis ophthalmic (eye) - | 0.05 % liquid |  | |
| Restasis ophthalmic (eye) - | 0.05 % liquid |  | |
| Verkazia ophthalmic (eye) - | 0.1 % liquid |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
cyclosporine oral
CYCLOSPORINE SOLUTION - ORAL
(SYE-kloe-SPOR-in)
COMMON BRAND NAME(S): Sandimmune
WARNING: Cyclosporine lowers your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect may also increase your risk of getting certain types of cancer (such as skin cancer, lymphoma). Tell your doctor right away if you have any signs of infection or cancer such as sore throat that doesn't go away, fever, chills, cough, burning/frequent urination, unusual skin changes, change in appearance or size of moles, unusual weight loss, swollen lymph glands, unusual lumps, night sweats.Cyclosporine can also cause high blood pressure and kidney problems. The risk of both problems increases with higher doses and longer treatment with this drug. Your doctor will monitor your blood pressure and kidney function while you take this medication.Psoriasis patients who have had certain previous treatments (such as coal tar, methotrexate, radiation treatment, light treatment with PUVA/UVB) are at increased risk to develop skin cancer. Talk to your doctor of the risks and benefits of this medication.Different brands of this medication may deliver different amounts of medication. Do not switch brands of cyclosporine without your doctor's permission and directions.
USES: Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own.
HOW TO USE: Take this medication by mouth as directed by your doctor, usually once daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.The dosage is based on your weight, medical condition, lab tests, and response to treatment.Carefully measure the dose using the medicine syringe provided. Do not use a household spoon because you may not get the correct dose. To help improve the taste, you should mix the measured dose with a glass of milk, chocolate milk, or orange juice that is at room temperature. Do not switch the liquid you use often. Make sure to use a glass cup and not a plastic cup. Drink all of the mixture right away. Do not prepare a supply in advance. To make sure you have taken all of the medication, rinse the glass with more liquid, then mix and drink. Consult your pharmacist if you have any questions.Dry the outside of the syringe after use. Do not rinse it with water. If the syringe must be cleaned, make sure that it is completely dry before using it again.Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
SIDE EFFECTS: See also Warning section.Shaking, headache, dizziness, unusual growth of body hair, nausea/vomiting, diarrhea, stomach upset, or flushing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Unusual growth and swelling of the gums may occur. Brush your teeth and floss daily to reduce this problem. See your dentist regularly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as a change in the amount of urine), signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal pain), easy bruising/bleeding, unusual tiredness, muscle weakness/spasms, slow/irregular heartbeat, numb/tingling skin, severe leg pain.Get medical help right away if you have any very serious side effects, including: mental/mood changes (such as confusion, difficulty concentrating), vision changes, problems with speech, clumsiness, loss of coordination, weakness on one side of the body, chest pain, seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood pressure, cancer, skin lesions of unknown cause, radiation treatment (including light treatment with PUVA or UVB), mineral imbalance (such as low level of magnesium or high level of potassium), recent/current infections, high cholesterol/triglycerides levels.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication may contain alcohol. Caution is advised if you are pregnant or breast-feeding or have liver disease, alcohol dependence, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.Cyclosporine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using cyclosporine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details.This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for kidney problems or high blood pressure while using this drug.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby or cause other problems with the baby such as being born too early (premature) or having low birth weight. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: coal tar, orlistat, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, tofacitinib), drugs that may increase potassium levels (such as potassium supplements, certain diuretics/"water pills" including amiloride, spironolactone), tacrolimus.Other medications can affect the removal of cyclosporine from your body, which may affect how cyclosporine works. Examples include bosentan, mifepristone, St. John's wort, among others.This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aliskiren, dabigatran, dronedarone, elagolix, certain statins (such as atorvastatin, pitavastatin, simvastatin), voxilaprevir, among others.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as kidney/liver function, blood pressure, blood mineral levels, cyclosporine blood levels, complete blood count, uric acid levels, lipid levels, skin exam) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant, yellowing of the skin/eyes with liver transplant, shortness of breath/inability to exercise with heart transplant). Get medical help right away if these symptoms of rejection occur.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store in the original bottle at room temperature. Do not refrigerate or freeze. Once the bottle has been opened, use the solution within 2 months. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
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